Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2011-09-30
2012-10-31
Brief Summary
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Detailed Description
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Design: Prospective pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.
Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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circumcision with simple circumcision device
Circumcision performed with the device in the operating room using local anesthesia
Eligibility Criteria
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Inclusion Criteria
2. Aged\>18
3. Sexually active
4. No plans for moving in next 6 months
5. Consent to participate
Exclusion
1. History of a bleeding disorder
2. History of a documented concurrent STI of appearance of an STI on initial physical exam
3. Keloid formation or other condition that might unduly increase risk of elective surgery
4. Asprin, anti-coagulants or other clinical contra-indications
18 Years
MALE
Yes
Sponsors
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University of Washington
OTHER
VA Puget Sound Health Care System
FED
Responsible Party
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John Krieger
Professor of Urology, University of Washington, Section chief Seattle VA urology division
Principal Investigators
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John N Krieger, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington/Seattle Puget Sound VA Health Care System
James M Hotaling, MD MS
Role: STUDY_DIRECTOR
University of Washington
Locations
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Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States
Countries
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Other Identifiers
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VAPSHCS-00434
Identifier Type: -
Identifier Source: org_study_id
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